Study of the Effect of Adjunctive Vivomixx® in Patients With Cirrhosis and Spontaneous Bacterial Peritonitis (SBP)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status and phase: Withdrawn; Phase 3

Conditions: Spontaneous Bacterial Peritonitis

Treatments: Drug: Vivomixx®; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02552862

IIBSP-VSL-2014-49

Details and patient eligibility

About

Study Design: Double-blind placebo-controlled clinical trial

Study Duration:2 years

Study Center: Hospital de la Santa Creu i Sant Pau, Barcelona (single center)

Objectives: To assess the effect of adjunctive Vivomixx® on bacterial translocation in patients with cirrhosis and SBP

Number of Subjects: 30

Main Inclusion Criteria: Patients with cirrhosis hospitalized with an episode of SBP at Hospital de la Santa Creu i Sant Pau

Study Product, Dose, Route, Regimen: Vivomixx ® sachets containing 450 x 109 bacteria, 2 every 12 hours during hospitalization (n=15), or placebo (n=15)

Duration of administration: During hospitalization due to SBP episode

Hypothesis: The adjunctive treatment with Vivomixx® in patients with cirrhosis and SBP could decrease bacterial translocation and systemic and cerebral proinflammatory state. This would result in a faster SBP resolution, a decrease in the incidence of complications and an improvement in cognitive function.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with cirrhosis hospitalized with an episode of SBP at Hospital de la Santa Creu i Sant Pau.

Cirrhosis will be diagnosed by clinical, analytical and ultrasonographic findings or by liver biopsy. SBP will be diagnosed by an ascitic fluid neutrophil count > 250/mm3 with or without positive culture .

Exclusion criteria

• Advanced hepatocellular carcinoma (beyond Milan's criteria) or any other malignancy.
• Advanced liver insufficiency [MELD (model for end-stage liver disease) >25].
• Active alcohol intake (in the previous 3 months).
• Neurological disease.
• Marked symptomatic comorbidities (cardiac, pulmonary, renal, untreated active depression, HIV infection).
• Previous antibiotic treatment, including norfloxacin and rifaximin.
• Septic shock, ileus, need for tracheal intubation or intensive care unit.
• Immunomodulatory drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Vivomixx®

Active Comparator group

Description:

Vivomixx® is a probiotic mixture of 8 proprietary strains. Thirty consecutive patients with cirrhosis and SBP will be randomized to receive Vivomixx® , sachets containing 450 x 109 bacteria, 2 every 12 hours during all the hospitalization until a maximum of 30 days (n=15), or placebo (n=15). All patients will receive endovenous antibiotics and also intravenous albumin 1.5 g/kg weight the first day and 1 g/kg weight the third day of treatment. The management of patients will follow current guidelines.

Treatment:

Drug: Vivomixx®

Placebo

Placebo Comparator group

Description:

Placebo will be formulated as identical in appearance and administered according to the same schedule as the active agent. Placebo contains maltose and silicon dioxide as inactive agent.

Treatment:

Drug: Placebo